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FDA 510(k) Application Details - K143592
Device Classification Name
Bacteriophage And Controls, B. Anthracis Lysis
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510(K) Number
K143592
Device Name
Bacteriophage And Controls, B. Anthracis Lysis
Applicant
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY
1430 VETERANS DRIVE
FORT DETRICK, MD 21702-5009 US
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Contact
Kenneth A. Bertram
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Regulation Number
000.0000
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Classification Product Code
NVQ
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More FDA Info for this Product Code
Date Received
12/18/2014
Decision Date
04/16/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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